The European Medicines Agency’s (EMA) COVID-19 task force (ETF) has decided not to recommend a fourth COVID-19 vaccine dose for the general population of the EU at this time. This decision was made in conjunction with the European Centre for Disease Prevention and Control (ECDC).
The fourth doses that were being considered are Pfizer’s Comirnaty and Moderna’s Spikevax – both mRNA COVID-19 vaccines.
However, both agencies agreed that adults aged 80 years and above can be given a fourth dose – or second booster – following data reviews. These reviews would evaluate the higher risk of severe COVID-19 in this particular age group and the protection benefits offered from a fourth dose.
Both the EMA and the ECDC stated that, at present, there is no clear evidence in the EU of a significant decrease in vaccine protection among adults aged 60 to 79 with regular immune systems.
As a result, it was concluded that there was no immediate and supporting evidence in favour of a fourth dose.
Regulators will continue to assess the data to see if there is a need for further protection from risk of severe illness among those who are vaccinated. Should the situation change, the agencies have recognised that it may become necessary to consider a fourth dose in this age group.
National authorities will also examine local data to determine if a fourth dose is needed for those who more vulnerable.
There is currently no conclusive evidence that vaccine protection against severe disease is decreasing, or that a fourth dose would make a substantial difference for those under 60 years of age with regular immune systems.
Re-vaccination programmes could begin in the autumn and regulators will have to decide on an appropriate time for further doses. As yet, no safety concerns have been reported from the studies on additional boosters.
Both the EMA and the ECDC have encouraged EU citizens to get both their initial and booster vaccinations, according to national recommendations and guidelines. As of the end of March this year, 83% of adults had received both initial vaccinations, but only 64% had received a booster dose.